Preventing Cognitive Decline With Alternative Therapies

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Portland,
Oregon97201

Purpose:

Preventing dementia is an important goal for our aging population. This proposal is an
initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on
preventing or delaying cognitive decline in people age 85 years or older (the oldest old).
The study focuses on the oldest old who present a distinct advantage for primary prevention
studies because of their particularly high risk for developing mild cognitive impairment
(MCI), a precursor to dementia. Because this is a population that has previously been out
of the mainstream for use of alternative medicine, the safety of GBE in this age group will
also be tested in this study. The study is randomized, placebo controlled and double blind.
Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for
detection of conversion to MCI. This pilot study is viewed as a necessary first step in
order to demonstrate that GBE, an alternative or complementary therapy, has a disease
modifying effect on the brain, distinct from a symptomatic effect. The study will test the
feasibility of the randomized start design, a trial design proposed as a method for
discerning brain- or disease- modifying from symptomatic effects. The magnitude of
biological effect of the treatments will also be assessed with volumetric quantitative MRI,
a complementary means of confirming whether there is a brain modifying effect (measured as a
decrease in brain volume loss with treatment). Peripheral markers of oxidation status will
measure possible anti-oxidant effects of GBE.

Study summary:

See brief summary

Criteria:

Inclusion Criteria:
- Can identify a collateral informant who has frequent contact with the subject
- No memory complaints compared to others of same age group and has not sought
attention for concerns about memory or cognition
- Normal memory function defined by an education-adjusted score on the Logical Memory
Subscale of the Wechsler Memory Scale-Revised
- Mini-Mental State Examination Score >23
- Clinical Dementia Rating (CDR) of zero